It is well known to employ sutures for the purpose of closing a wound or an incision created during an operation. For this reason, it is necessary that the suture be maintained in a sterile condition at all times prior to its use. Moreover, it is also necessary that the suture be readily available when needed so as to permit efficient and expeditious use thereof.
Typically, sutures are known which are contained in packages so as to preserve the sterile condition of the sutures. Such packages typically provide suitable arrangement of the sutures so as to prevent any entangling of the sutures upon their removal from the package. Such known sutures and their accompanying packages are described in U.S. Pat. Nos. 3,280,971; 3,939,969; 4,063,638; and 4,069,912.
Each of these patents relates to a suture package which contains sutures in a sterile condition prior to use. The '971 patent relates to a suture package intended to retain the suture strands in such a way that they can be removed easily from the package and will not be kinked or bent upon removal. The '971 patent package includes a coiled hollow restraining tube which is retained within a holding sleeve formed from a sterilizable stiff sheet material. The tube is large enough so that a plurality of sutures can be contained therein in a loose fashion and furthermore so that they do not entangle with one another during their storage. Outside of the tube, the sutures at their free end are attached to individual curved needles which are permitted to rest loosely in an unconstrained fashion upon the sheet material.
The '969 patent discloses a suture package including a suture retainer made up of three panels. The suture strand is coiled and placed upon a middle panel while the needle is curved back and superimposed over a second panel which in turn overlies the first panel. Moreover, a third panel thereafter overlies the second panel and thereby covers the needle itself. The third panel itself includes a tab at an end portion which upon being pulled away from the third panel permits separation along a tear line so as to expose the suture needle laying upon the second panel.
The '638 patent relates to a suture package also including an inner envelope consisting of three connected panels. As was the case in the '969 patent, the suture strand is placed or retained in a non-entangling configuration upon the second panel which may include strand retainers if desired. One of the end panels along this upper peripheral edge includes a series of perforations and slits extending therefrom to the peripheral edge so as to receive and retain an end portion of the strand. The needle which is attached to the end of the respective strand in turn is placed upon an end panel and is retained thereon by inserting the needle end through a slit provided in the end panel.
Similarly, the '912 patent also relates to a suture package wherein the needle attached to a suture surgical strand is retained underneath an overlapping panel of a suture label by inserting the needle through a slit contained in an overlapping panel portion. Accordingly, only a small portion of the needle is exposed and available for securing with a suitable device for removal of the needle therefrom.
Notwithstanding the improvements which the above-identified patents offer with respect to packages suitable for containing sutures in a sterile condition prior to use, these devices still present difficulties with which the operating personnel must cope.
Most of the presently known suture packages retain the needle portion of the suture in a flat abutting relationship with the packaging material itself. For this reason, removal of the suture is made difficult inasmuch as the needle lies flat against a panel. Typically, a nurse or surgeon is required to dig into the package to get at the needle. This problem is further complicated when dull needle holders are employed. In addition, none of the above-identified suture packages provide for arming from the pack or container either for right or left-handed suturing. Oftentimes, it is necessary for the nurse or surgeon to employ the needle holder as a removal tool since the needle is oftentimes buried in the package and thereafter in a subsequent step to reposition the needle in accordance with the surgeon's needs. For this reason, the suture packages described above do not present an armed suture which is physically convenient and readily viewable prior to use. Also, it is known in typical suture packages that the needle migrates out of its planned or intended location. As a result, the needle may not be found where expected and further searching within the suture package is required. This further complicates the process of removing the needle and suture from the package itself.
Such difficulties also involve the limited visibility which these patented devices provide with respect to the suture and their respective needles. Limited visibility does not permit an easy and efficient determination of the needle count and the product style prior to opening the package itself.
In addition, it is desirable to obtain efficient economy of use which results from not opening the wrong package. Such is the case where the package cover itself totally encloses the inner suture container and for this reason prevents the viewing of the type of suture enclosed. Moreover, it is desirable to permit viewing of the suture while within the container and thereby determine the true characteristics of the suture within without relying upon a two-dimensional description or illustration presented on the package cover.